Senior Manager, Quality

Vertex Inc.•Boston, MA

1d•Hybrid

About The Position

The Senior Quality Manager will be part of the Program Quality Team in Vertex’s North America Commercial Patient Support Program Center of Excellence (NAC PSP COE). The COE is a group of compassionate and determined individuals who provide operational support to our commercial Patient Support Programs (Cystic Fibrosis, Hematology, Diabetes and Kidney) in areas such as systems and technology, data and analytics, vendor management and program quality. Additionally, COE team members help design patient support offerings and policies for future Vertex Patient Support Programs (PSP). The Senior Quality Manager will play a meaningful role within the COE and contribute to the success of the PSP programs by leading aspects of our quality and compliance portfolio. As a subject matter expert, you will be responsible for monitoring and auditing compliance to the PSP policies as well as tracking corrective and preventative actions. You will report to the COE Director of Program Quality.

Requirements

A bachelor’s degree with 5+ year’s pharmaceutical/biotech industry experience
Experience working in a Quality or Compliance role or relevant comparable background in Patient Support
Intellectually curious with a continuous improvement mindset; high customer service aptitude, seeks to understand and self-educate on current trends in patient services quality programs
Understands how systems and databases are structured, has the ability to consolidate multiple data sources, and synthesize large datasets into key findings and recommendations.
Intermediate to advanced proficiency in data analysis tools such as Microsoft Excel
Strong collaboration skills with a high customer service aptitude

Nice To Haves

Experience in patient focused programs within associated HIPAA regulations and other legal parameters and patient privacy policies
Patient-centric and customer service minded
Product Launch experience of drugs with complex service models
Willingness to work in a fast-paced environment, and have the ability to multi-task and self-prioritize workload
Attention to detail, highly organized and committed follow-through in communication to internal and external partners
Ability to work independently yet function as a team player and experience collaborating offline and managing formal reviews with legal, compliance, marketing
Contributes to Vertex’s culture of compliance by focusing on ethics and integrity in all interactions and ability to role model the expected behavior for the team
Excellent communication skills, both written and verbal, with the ability to connect effectively with peers, as well as more diverse and large audiences
Comfortable working in a fast-paced, results-driven, environment, with the ability to multi-task and prioritize the workload of the team
Patient-centric and customer service minded
Demonstrated ability to effectively collaborate across multiple teams internally & externally
Ability to manage up and across an organization; can adeptly identify when/what information to share with leadership and/or cross-functional stakeholders at critical times

Responsibilities

Manage internal PSP audit programs; utilize metrics and analytics to provide insight into process adherence, assess skill gaps and ultimately inform appropriate and meaningful training programs (liaise with Commercial Training)
Conduct monthly communication monitoring (e.g. calls, texts, emails) of PSP engagement. Analyze data including trends, and recommend areas of improvement
Establish and support the development and implementation of quality and compliance standards, processes and measurement systems, deviation management
Audit external PSP vendors; lead assessment, present findings, and track outcomes /deliverables
Serve as a lead for PSP on internal audits conducted directly by Vertex personnel; oversee and engage on external audits conducted by a vendor on behalf of Vertex in collaboration with the Director of Quality
Presents findings to internal team and appropriate service providers (as needed)
Work closely with PSP stakeholders to ensure appropriate steps are taken to address audit findings/observations of nonconformance; ensures adequate and timely closure of CAPAs generated from audits
Act as the Privacy and Compliance champion to support an expanded Patient Support Specialist/Care Manager Team of varying tenure and experience
Manage current and future cross-functional projects that improve processes that support the multilayered Patient Services Team (e.g. guidance regarding community events, creating a template of shared resources between the Patient Services Team and the field)
As directed by the Director, liaise with the Office of Business Integrity and Ethics (OBIE), Legal, Privacy Office and other field facing teams to proactively enhance how our cross-functional teams can appropriately interact together and with external stakeholders; ensure guidance is clear, up to date, and pulled through.
Identify opportunities for operational efficiencies and continuous improvement and partner with colleagues in other disease areas to share learnings / best practices
Other responsibilities as assigned by the Director